The Manufacturing Supervisor works as part of the Manufacturing team to deliver on goals to generate high quality materials that can be used both in the clinic as well as commercial. This position will contribute to the successful delivery of released product in support of clinical trials and commercial requirements. The Manufacturing Supervisor will work in different activities including manufacturing processes, facility cleaning, document review, inventory control and materials management. The position will also provide manufacturing processing input for the design and operation of computer systems (MES, ERP, LIMS, QMS, EMS). The candidate will also understand the requirements needed to meet quality and regulatory compliance in the manufacturing environment.
Work Location: Thousand Oaks, CA
Reports to: Manager, Manufacturing
Travel Requirements: 10%
Primary Responsibilities
- Support production in an aseptic environment.
- Provide oversight to manufacturing operations personnel to ensure adherence to production schedule and GMP compliance.
- Assists in the day to day manufacturing operations and identifies improvement opportunities.
- Writes manufacturing documents pertaining to the manufacture of the company’s cellular therapies.
- Works with the quality group and contract manufacturing organization to support regulatory filings for the various clinical programs.
- Reviews completed batch records and initiates deviations when appropriate.
- Supports critical investigations into the manufacturing process operations.
- Performs scheduling of operations.
- Supports development, and technology transfer activities into manufacturing in the execution of change control, functional testing, and/or commissioning and qualification.
- Assists in the establishment of systems as they pertain to the new manufacturing facility.
- Creates, updates, and maintains manufacturing SOP’s to ensure they are in-line with the current process steps.
Physical Requirements:
- Subject to extended periods of sitting and/or standing in a clean room environment (ISO 7 or 5).
- Work is generally performed in an office, manufacturing clean room or clinical environment.
Education and Professional Experience:
- Master of Science (M.Sc.) with 3+ years of experience; or
- Bachelor of Science (B.Sc.) with 5+ years of experience; or
- Associate degree with 6+ years of experience; or
- High school diploma with 7+ years of experience
- Must be knowledgeable and worked in biotech manufacturing related industry.
- Demonstrated understanding of cGMP execution.
- Supervise personnel in a manufacturing environment.
Position Requirements:
- Strong communication skills (e.g., clear and concise), both written and verbal and a team player.
- Specific experience with ERP, MES, QMS, LIMS is a plus.
- Previous experience in manufacturing or operations environment.
- Experience with computer and documentation systems.
- Good decision making with strong judgment through collaboration and consideration of others point-of-view.
- Ability to understand manufacturing process and equipment related engineering tools, such as process flow diagrams, and/or engineering specifications/requirements.
- Experience with automation systems and equipment used in cell therapy manufacturing is a plus.
- Understanding of cGMP for cell therapy manufacturing.
- Flexibility to work on any shift required to accommodate the business needs.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Salary and Benefits:
- $41 to $52 per hour, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
